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This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
The global sourcing of ingredients has created complex supply chains, significant management challenges, and additional regulatory compliance requirements. This places tremendous pressure on food manufacturers, many of whom lack the knowledge, concepts, techniques, and procedures to comply with these increased requirements. Providing a roadmap for
This powerful resource identifies wide-scale health challenges facing a rapidly urbanizing planet--including key concerns in nutrition, health status, health care, and safety--and strategies toward possible solutions. Theoretical and empirical analysis focuses on maximizing the benefits of urban living and minimizing negative outcomes across areas for improvement (health education, maternal and child health) and threats to well-being (noise pollution, drug counterfeiting). For each challenge, contributors discuss implications for health, specific practices that fuel them, and emerging ideas for solving them efficiently and effectively. Not only are these issues of immediate salience, they will become dangerously urgent in years to come. Included in the coverage: Food fortification and other innovations to address child malnutrition. Anti-trafficking innovations, urbanization, and global health. Innovations to address global climate change in cities. Innovations in disaster preparedness: implications for urbanization and health. Medical diagnostic innovations in urban developing settings. The case for comprehensive, integrated, and standardized measures of health in cities. Recent studies suggest that urban areas will be a large majority in both the developing and developed worlds. Innovations to Address Urbanization & Global Health is a proactive idea book to be read by undergraduates, graduate students and researchers in public and urban health.
Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. - Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development - Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward - Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues - Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives - Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Presents a pragmatic agenda for achieving effective and sustainable global action on noncommunicable diseases in lower- and middle-income countries. Noncommunicable diseases (NCDs)—including cardiovascular disease, diabetes, asthma and other chronic respiratory conditions, and cancers—are the leading causes of death worldwide. An estimated 36 million people die from such diseases each year; this represents roughly two out of three deaths globally. Eighty percent of these fatalities occur in developing countries. The statistics are staggering, yet millions of these deaths are preventable. This is an urgent global health issue that demands analysis of gaps in NCD research, new policies and practices, and actionable recommendations to close the gaps. The Johns Hopkins Institute for Applied Economics, Global Health, and the Study of Business Enterprise convened an NCD Working Group of leading scholars to examine a wide range of issues that both the private and public sectors must address to make sustainable progress in NCD prevention and treatment in lower- and middle-income countries. Collected in this volume are essays on five key areas where strengthened policies and health systems can have the most impact in the near future. • Accelerating regulatory harmonization • Structuring supply chains • Improving access to interventions • Restructuring primary care • Promoting multisectoral and intersectoral action While there is a growing literature on the problem of NCDs, none of the available studies provides background on the range of challenges matched with specific steps that can be taken by the public sector, private sector, and civil society working together. Noncommunicable Diseases in the Developing World presents a framework for understanding the salience of specific policy recommendations and detailed steps that can be taken now to move forward in the global campaign against NCDs. This book will be of interest to practitioners, scholars, and students in public health as well as those framing and implementing health policies in the private and public sectors.

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United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

Published: 2014

Total Pages: 96


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